Pelvic Physical Therapy for Sexual Dysfunction in Gynecologic Oncology Survivors

Overseen By Study Nurse

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Active infection, Vaginal fistula, Active cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is investigating whether a program of pelvic physical therapy can help gynecologic cancer survivors who have sexual dysfunction. The therapy involves exercises and treatments to strengthen and relax pelvic muscles, improve blood flow, and reduce pain. Researchers want to see if this program is practical for patients and if it improves their sexual function and quality of life. Multimodal pelvic floor physical therapy (PFPT) has shown sustained improvements in pain and sexual function for gynecological cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Pelvic Physical Therapy?

Research shows that pelvic physical therapy can improve symptoms and quality of life for women with pelvic pain and other symptoms, and it helps adolescents and young adults with endometriosis perform daily activities better. It is also beneficial for treating high-tone pelvic floor dysfunction and fecal incontinence in children. ^{1 2 3 4 5}

Is pelvic physical therapy generally safe for humans?

Research indicates that pelvic physical therapy, including techniques like pelvic floor muscle training and myofascial trigger point therapy, is generally safe for humans. It has been used to manage conditions like chronic pelvic pain and sexual dysfunction, with studies focusing on its safety and effectiveness. ^{3 6 7 8 9}

How is pelvic physical therapy different from other treatments for pelvic pain?

Pelvic physical therapy is unique because it is a non-invasive treatment that focuses on strengthening and coordinating pelvic floor muscles to relieve pain and improve function. Unlike medications or surgeries, it involves exercises, manual therapy, and techniques like biofeedback and electrical stimulation, which can be combined with other treatments and have a low risk of side effects. ^{6 10 11 12 13}

Research Team

Suzanne Danhauer, PhD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Anya Menzies, PhD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

Inclusion Criteria

History of cervical, ovarian/fallopian tube/primary peritoneal, uterine, or vulvar/vaginal cancer, regardless of stage or amount of prior therapy. Patients must have completed radiation therapy 12 weeks prior enrollment. Patients must be at least 12 weeks remote from surgery. There is no minimum time after completion of chemotherapy for enrollment. There is no upper limit of time from treatment.

Age ≥18 years.

Screen positive for sexual dysfunction based on answers to the Brief Sexual Symptom Checklist for Women. A patient screens positive if they answer 'no' to the first question (Are you satisfied with your sexual function?) and if they select any answer other than 'a' in the third question (Mark which of the following problems you are having). The other questions do not impact whether a patient screens positive or negative. They do not have an impact on study eligibility.

Exclusion Criteria

Active pelvic infection.

You have a hole between your vagina and another organ, which can cause health problems.

Deemed not suitable for pelvic physical therapy based on physician assessment. If there is suspicion for infection, disease recurrence, or other concerning medical findings that necessitate further evaluation and work up at that time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week pelvic physical therapy regimen to address sexual dysfunction

10 weeks

Weekly visits for physical therapy

Follow-up

Participants are monitored for sexual function and quality of life improvements

6 months

Assessments at 3 months and 6 months post-treatment

Treatment Details

Interventions

• Pelvic Physical Therapy

Participant Groups

Group I: Physical Therapy Arm Experimental Treatment 4 Interventions

Physical therapy for sexual dysfunction.

Group II: Control Arm Placebo Group 1 Intervention

Educational pamphlet with resources for sexual dysfunction

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

In a study of 474 women undergoing pelvic floor physical therapy (PFPT), significant improvements were observed in validated symptom scores, particularly for pelvic pain, with median scores on the Pelvic Floor Distress Inventory (PFDI) dropping from 77.3 to 41.8 after treatment (P < 0.0001).

Women with pelvic pain showed notable enhancements in their quality of life and pain levels, meeting the minimal clinically important difference for multiple measures, indicating that PFPT is an effective intervention for alleviating pelvic floor symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom and Quality of Life Improvements After Pelvic Floor Physical Therapy in a Clinical Population of Women With Pelvic Pain and Other Symptoms. Killinger, KA., Henrichsen, JL., Han, E., et al.[2021]

A survey of 53 physical therapists in a rural healthcare setting revealed that 58% received less than 2 hours of training in pelvic floor physical therapy (PFPT) during their graduate education, indicating a significant gap in initial training.

Despite the low training levels, 95% of therapists pursued additional post-graduate training in PFPT, suggesting a strong commitment to improving their skills to better serve patients with pelvic floor dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training of Physical Therapists in Pelvic Floor Techniques: Is Care Available in the Rural Midwest? Biach, V., van Oosbree, A., Cookson, N., et al.[2023]

Radiotherapy for gynecological cancers often leads to significant side effects in women, such as vaginal dryness, stenosis, and pain, affecting their sexual health, as analyzed in 19 studies involving 2,739 women.

While there is some evidence suggesting that pelvic floor muscle training (PFMT) may help manage sexual dysfunction after radiotherapy, the current studies are limited in quality and quantity, indicating a need for more rigorous research to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training. Barcellini, A., Dominoni, M., Dal Mas, F., et al.[2022]

A qualitative study involving 28 gynecological cancer survivors found that multimodal pelvic floor physical therapy (PFPT) is acceptable and beneficial for treating dyspareunia, with participants reporting significant improvements in their condition.

Despite some participants finding the treatment intensity demanding, overall satisfaction was high, and all participants recommended the therapy, highlighting its effectiveness and relevance in their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of multimodal pelvic floor physical therapy to treat dyspareunia after gynecological malignancies: a qualitative study of women's views and experiences. Cyr, MP., Dostie, R., Camden, C., et al.[2023]

Pelvic physical therapy is an effective first-line treatment for various types of urinary incontinence, offering non-invasive symptom relief with low risk of side effects and moderate costs, making it suitable for a wide range of patients including women, men, children, and the elderly.

Specific interventions like pelvic floor muscle (PFM) training and electrical stimulation have been shown to improve outcomes, particularly after radical prostatectomy in men, by reducing incontinence duration and enhancing quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of the pelvic physical therapist]. Berghmans, B.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Symptom and Quality of Life Improvements After Pelvic Floor Physical Therapy in a Clinical Population of Women With Pelvic Pain and Other Symptoms. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Pelvic Floor Physical Therapy on Function in Adolescents and Young Adults with Biopsy-Confirmed Endometriosis at a Tertiary Children's Hospital: A Case Series. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Barriers to Pelvic Floor Physical Therapy Regarding Treatment of High-Tone Pelvic Floor Dysfunction. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Physical Therapy for Fecal Incontinence in Children with Pelvic Floor Dyssynergia. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Training of Physical Therapists in Pelvic Floor Techniques: Is Care Available in the Rural Midwest? [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Physical therapy for pregnancy-related low back and pelvic pain: a systematic review. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Sexual Health Dysfunction After Radiotherapy for Gynecological Cancer: Role of Physical Rehabilitation Including Pelvic Floor Muscle Training. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of an internal pelvic myofascial trigger point wand for urologic chronic pelvic pain syndrome. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Acceptability of multimodal pelvic floor physical therapy to treat dyspareunia after gynecological malignancies: a qualitative study of women's views and experiences. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of Manual Therapy for Treatment of Dyspareunia in Females: A Systematic Review. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Group-based multimodal physical therapy in women with chronic pelvic pain: A randomized controlled trial. [2020]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic Review of the Effectiveness of Physical Therapy Modalities in Women With Provoked Vestibulodynia. [2018]

13. Spain pubmed.ncbi.nlm.nih.gov

[The role of the pelvic physical therapist]. [2019]